The Impact of Continuous Glucose Monitoring on Maternal and Infant's Outcomes in Gestational Diabetes

NCT06436326 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-07-22

No results posted yet for this study

Summary

This study will discuss the impact of continuous glucose monitoring on maternal and infant's outcomes in gestational diabetes mellitus, and test the moderating effect of socioeconomic and cultural factors (dietary habits, socioeconomic status and income).

Conditions

  • Gestational Diabetes Mellitus
  • Continuous Glucose Monitoring

Interventions

DEVICE

Continuous glucose monitor

Participants will receive a set of continuous glucose monitor (CGM) at "24-32 weeks of pregnancy (first set)" and "33 weeks of pregnancy to before delivery (second set)," respectively. CGM wearing instruction will be provided before the first wearing at "24-32 weeks of pregnancy". After completing the first wearing (approximately 14 days after starting to wear), the investigators will provide a glucose monitor report. The second CGM was worn from the 33rd week of pregnancy to before delivery, and another glucose monitor report was given approximately 14 days after starting to wear.

BEHAVIORAL

Perinatal nursing care for gestational diabetes

Individual nursing care and consultation for pregnant women with gestational diabetes mellitus, including glucose monitor suggestions, dietary suggestions, emotional support, breastfeeding support.

OTHER

Blood glucose meters (BGM)

Participants are required to use blood glucose meters (BGM) at "24-32 weeks of pregnancy" and "33 weeks to before delivery". After 14 days of glucose monitoring at "24-32 weeks of pregnancy", a glucose monitor report will be given to the participants. After the 14 days of glucose monitoring at "33 weeks to before delivery ", another glucose monitor report will be given to the participants.

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • HUNG-HUI CHEN, PhD · National Taiwan University Hostiptal

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-22
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Device
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06436326 on ClinicalTrials.gov